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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K850928
Device Name V.E.P. HIP -VARIABLE ENDO-PROSTHESIS
Applicant
Unitas Ent.
766 Francisco St.
San Francisco,  CA  94133
Applicant Contact MICHAEL M STEK
Correspondent
Unitas Ent.
766 Francisco St.
San Francisco,  CA  94133
Correspondent Contact MICHAEL M STEK
Regulation Number888.3360
Classification Product Code
KWL  
Date Received03/05/1985
Decision Date 05/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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